A Regenerative Medicine Company Advancing Disruptive Stem Cell .

1y ago
4 Views
1 Downloads
4.34 MB
20 Pages
Last View : 11d ago
Last Download : 3m ago
Upload by : Aarya Seiber
Transcription

A REGENERATIVE MEDICINE COMPANY ADVANCINGDISRUPTIVE STEM CELL TECHNOLOGY PLATFORMSINVESTOR PRESENTATIONMARCH 2022NASDAQ: CELZ

The information contained in this presentation contains certain forward-looking statements. Allstatements other than statements of historical facts contained or incorporated by reference in thispresentation, including statements regarding our future financial position, business strategy and plansand objectives of management for future operations, are forward-looking statements. The words“anticipate,” “believe,” “estimate,” “will,” “may,” “future,” “plan,” “intend” and “expect” and similarexpressions generally identify forward-looking statements. These forward-looking statements are notguarantees and are subject to known and unknown risks, uncertainties and assumptions that maycause our actual results, levels of activity, performance or achievements to be materially different fromany future results, levels of activity, performance or achievements expressed or implied by suchforward-looking statements. Although we believe that our plans, intentions and expectations reflectedin the forward-looking statements are reasonable, we cannot be sure that they will be achieved.Particular uncertainties that could cause our actual results to be materially different than thoseexpressed in our forward-looking statements include: our history of losses; our inability to receiveregulatory approval for our products; later discovery of previously unknown problems; reliance on thirdparties; competition between us and other companies in the industry; delays in the development ofproducts; our ability to raise additional capital; continued services of our executive management team;and statements of assumption underlying any of the foregoing, as well as other factors set forth underthe caption “Risk Factors” in our annual report on Form 10-K, and other subsequent filings, with theU.S. Securities and Exchange Commission. All subsequent written and oral forward-looking statementsattributable to us, or persons acting on our behalf, are expressly qualified in their entirety by theforegoing. Except as required by law, we undertake no obligation to update any forward-lookingstatement, whether as a result of new information, future events or otherwise.2

WHO IS CREATIVE MEDICAL TECHNOLOGY? We are focused on developing and marketingbreakthrough regenerative stem cell therapies,including a potentially revolutionary immunotherapyplatform for the treatment of multiple indications.HeadquartersYear Formed / Reverse MergerExchange / Ticker We manage commercial-stage products whilesimultaneously advancing a robust developmentpipeline. We own an extensive IP portfolio grounded inregenerative medicine in the areas of immunology,urology, neurology, and orthopedics. We are fully dedicated to supporting a growingnetwork of physician partners and developingadditional therapeutic solutions that improve patientquality of life and health outcomes.Phoenix, AZ2016NASDAQ / CELZNASDAQ Uplist DateDecember 2021Recent Price (3/4/22) 1.67Shares Outstanding1 6.3 mmMarket Capitalization (3/4/22)1 10.5 mmTotal Cash (9/30/21)1 11.5 mmTotal Debt (9/30/21)1 0.0 mmEnterprise Value (3/4/22) (1.0) mm1 Proforma for offering of 3.875 million shares at 4.13 per share, whichclosed on December 7, 2021.3

Strong Management Team and Scientific Advisory BoardDisruptive Technology in Regenerative MedicineRobust Development PipelineSubstantial Addressable MarketsHigh Potential Commercial ProductsDevelopment Catalysts on the Horizon4

STRONG MANAGEMENT TEAM AND SCIENTIFIC ADVISORY BOARDTim Warbington – Chief Executive Officer, President and DirectorCamillo Ricordi, MD, Scientific Advisory Board 25 years of executive leadership experience Provided strategic consulting and invested in multiple biotech companies, and leda multi-million dollar national agricultural and finance companyProfessor of Surgery, Distinguished Professor of Medicine, Professor of BiomedicalEngineering, Microbiology and Immunology at University of Miami Director of UofM’s Diabetes Research Institute and the Cell Transplant CenterDon Dickerson – Chief Financial Officer, DirectorBoris Reznik, A.S., M.S., Ph.D., Scientific Advisory Board 20 years of finance and operational leadership experience primarily in thepharmaceutical, technology and finance industries Chairman of Venvalo Group Prior companies: Medistem, GMT Ventures, JP Morgan, Boeing, and Dell 40 years investing in and building multiple technology-based companiesSahil Nock – Chief Commercial OfficerTimothy Henry, MD, Scientific Advisory Board 15 years of leadership experience in sales, marketing, & business development Director of Cardiology, Christ Hospital, Cincinnati, Ohio Prior companies: Johnson & Johnson, Intrexon, Abbott, Beckman CoulterDiagnostics, Thermo Fisher Scientific, and Microsoft Former Director of Research at Minneapolis Heart Institute FoundationCourtney Bartlett – Director of Clinical DevelopmentSantosh Kesari, MD, Ph.D., Scientific Advisory Board 10 years of leading clinical research efforts in cell and gene therapy Former co-investigator on several widely publicized stem cell clinical trialsperformed by public companies such as Capricor, TEVA, VeriCel, and AstellasDirector, Neuro-oncology; Chair and Professor, Department of TranslationalNeurosciences and Neurotherapeutics, John Wayne Cancer Institute5

AreaApplication/Patent #DescriptionUrology8,372,797Treatment of Erectile Dysfunction by Stem Cell TherapyUrology10,792,310Methods for Treatment of Premature Ovarian Failure and Ovarian Aging Using Regenerative CellsUrology63302228Regenerative Cell Therapy for Viral Induced Sexual DysfunctionUrology16799656Extracorporeal Shock Wave Ultrasound for Enhancement of Regenerative Activities in Erectile DysfunctionOrthopedics9,598,673Treatment of Disc Degenerative DiseaseOrthopedics10,842,815Perispinal Perfusion by Administration of T regulatory Cells Alone or in Combination with Angiogenic Cell TherapiesNeurology15702735Inducing and Accelerating Post-Stroke Recovery by Administration of Amniotic Fluid Derived Stem CellsNeurology15987739Generation of Autologous Immune Modulatory Cells for Treatment of Neurological ConditionsImmunology63123380Induction of Infectious Tolerance by Ex Vivo Reprogrammed Immune CellsImmunology63297883Regenerative CAR-T CellsImmunology63297876Chimeric Antigen Receptor Regenerative Gamma Delta T CellsImmunology17585356Treatment of Kidney Failure using Ex Vivo Reprogrammed Immune CellsImmunology17559985Treatment of Liver Failure by Ex Vivo Reprogrammed Immune CellsImmunology17559970Treatment of Heart Failure and/or Post Infarct Pathological Remodeling by Ex Vivo Reprogrammed Immune CellsImmunology63138776Treatment of Diabetes Using Immune Cells Reprogrammed Ex Vivo by Regenerative CellsImmunology63208249Prevention and/or Treatment of Type 1 Diabetes by Augmentation of Myeloid Suppressor Cell ActivityImmunology63223245Therapeutic Monocytic Lineage CellsImmunology63313313Potency Assay6

ROBUST DEVELOPMENT PIPELINE & SUBSTANTIAL ADDRESSABLE MARKETSSUPERCHARGED AUTOLOGOUS IMMUNOTHERAPY PLATFORMImmCelz For StrokeImmCelz For Type I DiabetesImmCelz For Heart DiseaseImmCelz For Liver DiseaseImmCelz For Kidney Disease*TAM references available upon requestIND filed with FDA 700,000# of people with ischemic stroke per year (US) 1.3 million# of people with type I diabetes (US) 30 million# of people with heart disease (US) 4.5 million# of people with liver disease (US) 37 million# of people with kidney disease (US)8

SUPERCHARGED AUTOLOGOUSIMMUNOTHERAPY PLATFORMThe ProcessExtract patient PBMC by (same as CAR-T)Culture under proprietary conditions to expandTreg and other immune cells from the patientz1324Inject back into patientIncubate PBMC with SecretedFactors from StimulatedDonor CellsImmCelz License from Jadi Cell, LLC - Provides Creative Medical Technology with an exclusive license to Patent No.9,803,176 and the proprietary process of expanding the master cell bank in the field of enhancing autologous cells.9

SUPERCHARGED AUTOLOGOUSIMMUNOTHERAPY PLATFORMImmCelz for Multiple IndicationsThe Concept Utilizes secreted factors from universal donor stemcells to “reprogram” the patient’s own immune cells Patient’s cells are cultured and becomesupercharged immune cells. They are thenharvested and injected back into patient in less than72 hours. Immune cells are significantly smaller in size thanstem cells and more effectively penetrate damagedareas to induce repair and regenerationImmCelz optimizes a patient’s own immunecells for treating multiple indications.10

SUPERCHARGED AUTOLOGOUSIMMUNOTHERAPY PLATFORMImmCelz Lead-Out Indication: StrokeJadi Cell License Existing GMP universal donor stem cell line Master cell bank registered with the FDA ImmCelz patents provide flexibility for use ofallogenic cells from other sourcesFiled IND Phase I for Stroke Uses existing universal donor stem line 4 groups of 8 patients per group Patients followed for 12 months - both safetyand efficacy examinedFirst ever clinical trial using cellular immunotherapy for treatment of stroke11

ROBUST DEVELOPMENT PIPELINE & SUBSTANTIAL ADDRESSABLE MARKETSRAPID AUTOLOGOUS STEM CELL PLATFORMCaverStem For Erectile Dysfunction (“ED”)FemCelz For Female Sexual DysfunctionStemSpine For Chronic Lower Back PainOvaStem For Premature Ovarian Failure*TAM references available upon request 18 million# of men with erectile dysfunction (US) 40%of premenopausal women per yearsuffering from sexual dysfunction (US) 16 million# of people experiencing chronic lowerback pain (US) 7 million# of women per year seekinginfertility treatment (US)13

RAPID AUTOLOGOUS STEM CELL PLATFORMTHE PROCESS1Harvest Patient’sBone MarrowStem CellsInjectionHarvested stem cell product containingendothelial progenitor cells, hematopoieticand mesenchymal cells without dilutionor contamination of bloodNo rejection2Stimulates natural healing andimprovement of muscle andblood vessels45 Minute Outpatient Procedure Performed Under Local Anesthetic Using Closed System Devicethat Does Not Require Centrifuge / Filters and is FDA Compliant Under 21 CFR 127.15(b)**Programs have not been evaluated by FDA14

RAPID AUTOLOGOUS STEM CELL PLATFORMFOR ERECTILE DYSFUNCTIONCaverStem Program Published Clinical Trial1 in Journal of Translational Medicine 140 patient refractory to PDE5 inhibitors Statistically significant improvement with no adverse reactionsCurrently offered by multiple providers nationwideAccelerators:oExhibiting at AUA in May 2022 to drive physician awarenessoLaunching physician recruitment campaign in-house and viacontract sales organizationoIncrease marketing efforts by onboarding social media leadoExpand to plastic surgery offices – experienced with sellingelective surgeriesoExplore co-marketing partnerships with other companies sellingto urologists and plastic bmed/18211591 and https://www.ncbi.nlm.nih.gov/pubmed/1659543815

RAPID AUTOLOGOUS STEM CELL PLATFORMFOR FEMALE SEXUAL DYSFUNCTIONFemCelz Program5 patient pilot completedoPatients experienced increased sensitivity and reducedpainoNo adverse effectsCurrently offered by multiple providers nationwideAccelerators:oEstablish a clinical registry with plans to publish results inpeer-reviewed journaloLaunching physician recruitment campaign in-house andvia contract sales organizationoIncrease marketing efforts by onboarding social medialeadoExplore co-marketing partnerships with other companiesselling to plastic surgeons16

RAPID AUTOLOGOUS STEM CELL PLATFORMFOR CHRONIC LOWER BACK PAIN MANAGEMENTStemSpine ProgramCompleted a pilot study of 15 patients with over12 months of data showing safety and efficacyoSignificant improvement in mobility andreduction in painoPain changed from 8.9 at baseline to 4.3 at30 days, sustained to 1.8 at 6 months and1.3 at 12 monthsCommercially available –recruitment of providers to beginAccelerators:oTwo-year data arriving soonoRoll-out of physician and patient awarenesscampaignCells injected aroundthe disc, not in the discNew blood vesselsincrease circulationaround the disc andrepair and replacedamaged tissue17

RAPID AUTOLOGOUS STEM CELL PLATFORMFOR PREMATURE OVARIAN FAILUREOvaStem ProgramFiled patent covering use of “regenerative cells” for treatment of ovarianfailure (age-associated female infertility). Studies show that stem cells can: Reduce ovarian fibrosis Accelerate maturation of immature oocytes Restore growth factor production damaged by agingCommencing discussion with providers to pilot OvaStem programAccelerators: Set up and enroll patients in clinical registry Identify KOLs to present on podium at various fertilityconferences Launch mass PR campaign highlighting first success story18

SUMMARYStrongManagementTeam andScientificAdvisoryBoardDisruptiveTechnology stantialAddressableMarketsHigh PotentialCommercialProductsDevelopmentCatalysts onthe Horizon19

Sahil Nock, Chief Commercial Officers.nock@creativemedicaltechnology.comKalle Ahl, CFAkahl@equityny.com20

cells to "reprogram"the patient's own immune cells Patient's cells are cultured and become supercharged immune cells. They are then harvested and injected back into patient in less than 72 hours. Immune cells are significantly smaller in size than stem cells and more effectively penetrate damaged areas to induce repair and .

Related Documents:

3 CAQSM, RMSK, ARDMS; The Center for Sports Medicine & Wellness, Glen Mills, PA 4 Regenerative and Orthopedic Sports Medicine, Annapolis, MD expected to be over 67 billion dollars in spending on biologics and cell therapies by 2020 (1). Specifically, regenerative medicine also stands in contrast to treatment modalities that impair

Human Stem Cell Research and Regenerative Medicine 6 The use of stem cells has developed under much expectation and even controversy worldwide, par-ticularly there where human embryonic stem cells (hESCs) are concerned. The enormous potential of regenerative medicine for restoring tissue or organ function and benefitting mankind has been

equine medicine b. Food animal or large animal medicine c. Exotic animal medicine d. Marine animal medicine (mammal and fish) e. Poultry medicine f. Wildlife medicine and aquaculture medicine 2. Discuss with your counselor the roles a veterinarian plays in the following: a. Public health medicine and zoonotic disease surveillance and control b .

DEPARTMENT DIVISION NAME Family Medicine Palliative Medicine Algu,Kavita Palliative Medicine Arvanitis,Jennifer Palliative Medicine Berman,Hershl (Hal) Palliative Medicine Buchman,Stephen (Sandy) Palliative Medicine Cellarius,Victor Palliative Medicine Goldman,Russell Palliative Medicine Hashemi,Narges Palliative Medicine Howe,Marnie

Experimental Analysis of an Regenerative Air Preheater In Boiler TPS- 1 Expansion Manuscript id. 371116084 www.ijstre.com Page 19 Even maintaining the ―Regenerative Air Preheater‖ in the correct way will result in the efficiency improvement. Sl. DATA UNIT No. 30-1-16 to16-02

SEPTEMBER 2020 REGENERATIVE AGRICULTURE and the SOIL CARBON SOLUTION. Table of Contents 3 Executive Summary 5 Introduction 9 A Potent Corrective 11 Regenerative Principles for Soil Health and Carbon Sequestration

Family Medicine Hougas, III, James Ehrling Bergquist Hospital Offutt AFB NE Family Medicine Howard, Sarah Clarkson Family Medicine Residency Omaha NE Family Medicine McNab, Molly Family Medicine Spokane Spokane WA Family Medicine Monson‐Walker, Jeanette Family Medicine Residency of Idaho Boise ID

to keep abreast of emerging trends and critical turns of the development of the collective knowledge. Areas covered: A progressively synthesized network is derived from 35,963 original research and review articles that cite 3875 articles obtained from an initial topic search on regenerative medicine between 2000 and 2011.